Pharmacokinetics and Pharmacodynamics of Novel Long-Acting Ropeginterferon Alfa-2b in Healthy Chinese Subjects.
Journal
Advances in therapy
Journal Volume
38
Journal Issue
9
Pages
4756 - 4770
ISSN
1865-8652
Date Issued
2021-09
Author(s)
Tsai, Chan-Yen
Tsai, Chung-Wei
Wang, William
Zhang, Jingjing
Qin, Albert
Teng, Chingleou
Song, Bo
Wang, Mei-Xia
Abstract
Ropeginterferon alfa-2b is a novel mono-pegylated human recombinant interferon (IFN) with the addition of N-terminal proline covalently attached by a 40-kDa polyethylene (peg) moiety. The present study aimed to evaluate the pharmacokinetics (PK), pharmacodynamics (PD) profiles and safety of the product in healthy Chinese.
Forty subjects were enrolled and treated with a single subcutaneous injection of either 180 mcg peg-IFN alfa-2a or 90, 180, and 270 mcg ropeginterferon alfa-2b.
The mean T of ropeginterferon alfa-2b was 92-141 h and the elimination half-life was 78-129 h. Dose-related, non-proportional increase in ropeginterferon alfa-2b exposure was observed, which was higher than for peg-IFN alfa-2a. The PD parameters were similar between each dose level of ropeginterferon alfa-2b. The mean T of β-microglobulin ranged from 118 to 132 h after a single dose of ropeginterferon alfa-2b. The average E was 3 mcg/ml in all dose levels and the mean AUEC ranged from 1608 to 1775 h/mcg/ml. The TEAEs were comparable among each treatment group and no death nor drug-related SAE was reported.
Ropeginterferon alfa-2b is safe and well tolerated after a single subcutaneous injection up to 270 mcg in healthy Chinese.
Subjects
Clinical trial
Healthy population
Pegylated interferon
Phase I
SDGs
Type
journal article